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Men using the RestoreX traction device saw a median 1.6-cm increase in length at 6 months, versus a median of 0.3 to 0.7 cm for controls.
Use of a novel penile traction device significantly increased penile length and preserved erectile function in men who have undergone a prostatectomy, an investigator reported at the 2020 Sexual Medicine Society of North America Annual Fall Scientific Meeting.1
Men using the RestoreX (PathRight Medical) traction device saw a median 1.6-cm increase in length at 6 months, versus a median of 0.3 to 0.7 cm for controls in the randomized, open-label study, according to David Yang, MD, andrology fellow at Mayo Clinic, Rochester, Minnesota.
Patients reported no change in erectile function at 6 months, and noted a slight improvement in satisfaction compared to decreases in both of those end points in the control arm, Yang said of the study, which has accrued 82 patients, including 55 who had reached 6-month follow-up at the time of this report.
Although larger numbers of patients and external studies are needed to validate the results, Yang said the current findings suggest RestoreX penile traction therapy may be a promising approach for improving penile length, spontaneous erections, and sexual satisfaction without the need for use of on-demand therapy with a phosphodiesterase 5 (PDE 5) inhibitor.
“This is the first noninvasive treatment option in the postprostatectomy setting that has randomized controlled evidence of improvements in both erectile function and penile length, so hopefully this will drive further research and protocols for penile rehabilitation,” Yang said.
Previous research demonstrated that RestoreX penile traction therapy improved penile curvature, length, and erectile functioning in men with Peyronie disease, according to Yang.
In a randomized, single-blind, controlled trial reported by Mayo Clinic investigators in 2019 in the Journal of Urology,2 110 men were randomized 3:1 to penile traction therapy or a control group. Using the device 30 to 90 minutes per day for 3 months not only improved curvature in 77%, but also significantly improved erectile function as measured by the International Index of Erectile Function (IIEF) questionnaire, and increased penile length by 1.6 cm versus 0 cm in controls.2
“Seeing that improvement in penile length led us towards this study looking at use of RestoreX in the postprostatectomy setting, because a common complaint between these 2 patient populations is loss of penile length,” said Yang, who was a coinvestigator in the Peyronie disease study.
Loss of penile length and erectile dysfunction are very common after prostatectomy, according to Yang, who said in his virtual SMSNA presentation that 15% to 68% of men report loss of penile length post prostatectomy.
“Prior studies looking at penile rehabilitation (post prostatectomy) have not demonstrated with high-level data any significant benefit of PDE 5 inhibitors, or vacuum devices for erectile function recovery,” he added.
Unique features of RestoreX include secure clamping of the penis and the ability to adjust traction without removing the device, Yang said.
To evaluate the efficacy of RestoreX in the postprostatectomy setting, Yang and colleagues initiated a randomized, controlled trial of 82 men (mean age, 58 years), including 55 patients for whom 6-month follow-up data were available as of this report.
At 1 month post prostatectomy, the men were randomly allocated to a control arm, or 1 of 2 penile traction therapy arms (30 minutes 5 times a week or 60 minutes 7 times a week) for 5 months, followed by a 3-month open-label phase.
At 6 months, a statistically significant increase in median penile length was observed in the traction group versus the control group, according to the investigators. Patients using traction had a 1.6-cm increase in length as measured to the corona, compared to 0.3 cm in the control group (P < .01). Likewise, the traction patients had a 1.6-cm length increase as measured to the tip, compared to 0.7 cm in the control group (P= .01).
More than 50% of traction patients said they were satisfied with their penile length at 6 months, compared to 11% in the control arm (P < .001).
Significant differences were seen in both erectile function and intercourse satisfaction favoring the patients treated with RestoreX, according to Yang. The RestoreX group saw no change from baseline to 6 months in the erectile function domain of the IIEF, whereas scores decreased in the control group. Intercourse satisfaction measured by IIEF increased slightly in the traction patients, compared to a decrease in the control arm.
Eighty-seven percent of men treated with RestoreX said they would use the device again, whereas 13% said they were unsure, according to the report.
No major adverse events were reported among any of the 55 patients with 6-month follow-up, according to Yang.
Beyond Peyronie disease and the postprostatectomy setting, RestoreX is also being evaluated in a randomized controlled trial including men with diabetes. Preliminary data, also reported at the 2020 SMSNA meeting,3 included statistically significant improvements in penile length, suggesting the traction device could be a viable approach to a common and difficult-to-treat problem, according to Yang and coinvestigators.
1. Yang D, Ziegelmann M, Manka M, et al. Efficacy of RestoreX penile traction therapy in improving penile length and erectile function post prostatectomy. Abstract presented at: 2020 Sexual Medicine Society of North America Annual Fall Scientific Meeting; November 9-15, 2020; Virtual. Session 5.
2. Ziegelmann M, Savage J, Toussi A, et al. Outcomes of a novel penile traction device in men with Peyronie’s disease: a randomized, single-blind, controlled trial. J Urol. 2019;202(3):599-610. doi:10.1097/JU.0000000000000245
3. Yang D, Ziegelmann M, Manka M, et al. Use of RestoreX penile traction therapy for treatment of penile length loss in diabetic men. Abstract presented at: 2020 Sexual Medicine Society of North America Annual Fall Scientific Meeting; November 9-15, 2020; Virtual. Session 4.